Today, skin cancer is so prevalent that its making people think twice before they venture outside without some SPF, and an increasing number would rather reach for something that skips the harsh chemicals. As a small business, it is not impossible to produce your own sunscreen products, however, it is also necessary when manufacturing these types of products to keep FDA requirements in mind.

Days are getting longer, the sun is shining, temperatures are rising and it’s days like these that get people in the mood for a little sun worship. But, did you know that skin cancer is the most common form of cancer in the United States? More than 3.5 million skin cancers in over two million people are diagnosed annually[1]. Facts like these compel the common consumer to run for the sunscreen. This causes a chain reaction because skincare companies want a piece of the action, but they also know that consumers want a sunscreen product that is “natural” and doesn’t contain chemicals of concern.

It is certainly compelling for small skincare manufacturers who want to gain market share by offering “natural” sunscreen. However, use of the term "sunscreen" or similar sun protection terminology in a product's labeling generally causes the product to be subject to Food & Drug Administration (FDA) regulation as a drug. Some ingredients approved as "sunscreens" may have alternate purposes in a product, such as titanium dioxide to make the product white. To avoid consumer misunderstanding, if a cosmetic product contains a sunscreen ingredient and uses the term "sunscreen" or similar sun protection terminology anywhere in its labeling, the term must be qualified, in accordance with 21 CFR 700.35(b), by describing the benefit to the cosmetic product provided by the sunscreen ingredient (for example, "Contains a sunscreen to protect product color."). Otherwise, the product may be subject to regulation as a drug (21 CFR 700.35)[2].

There are two basic types of sunscreen products on the market: products that penetrate the outermost layer of skin to absorb ultraviolet rays, and products which coat the surface of the skin to act as physical barriers to ultraviolet rays. Both of these types are rated with a sun protection factor (SPF), which lets the consumer know how much protection against UVB rays the product provides. Any product that declares a SPF on the label, qualifies as a sunscreen and is beholden to FDA requirements for Over The Counter (OTC) drug products. OTC monographs define the safety, effectiveness, and labeling of OTC active ingredients. If a drug is in the OTC final monograph, companies can manufacture and market that OTC product without FDA pre-approval[3].

Regulatory hurdles pose the greatest barrier to entry into the Sunscreen Manufacturing industry[4]. In order to sell a sunscreen product, your company must follow one of two avenues:

To manufacture and sell your own sunscreen, you must follow the Food & Drug Administration guidelines for OTC drug products:

FDA Registration: Sunscreen manufacturers must register with the FDA, work under GMP guidelines, and update their list of drug products twice annually.

Labeling rules: All sunscreen ingredients must be listed separately in the ingredient list under "active ingredients" together with the concentration used in the product.

Validation of claims: Claims made on the label suggesting that the product offers sun protection (UVA and/or UVB) must be substantiated with clinical and/or in-vitro testing.

Alternately, there are numerous private label manufacturers who can manufacture sunscreen products according to FDA guidelines and package those products under your company name. This process ensures the following:

FDA Registration: Sunscreen “distributors” are not required to register with the FDA. This is the responsibility of the sunscreen manufacturer. As long as you are distributing a sunscreen manufactured by a qualified contract manufacturer, it is that manufacturers responsibility to register the manufacturing facility and the formula. They must work under GMP guidelines and update their list of drug products twice annually.[5]

Labeling rules: All sunscreen ingredients must be listed separately in the ingredient list under "active ingredients" together with the concentration used in the product. Your contract manufacturer should provide you with labels that follow FDA labeling guidelines for OTC drugs.

Validation of claims: It is the responsibility of the contract manufacturer to ensure that the claims made on the label suggesting that the product offers sun protection (UVA and/or UVB) are substantiated with clinical and/or in-vitro testing. Your contract manufacturer should be able to provide you with documentation corroborating any product claims.

Offering sunscreen products is not an unattainable goal, but it is imperative that your small business be aware of the requirements prior to marketing this class of products. Failure to comply with FDA guidelines may result in regulatory action including (but not limited to) your product being classified as misbranded, mandatory product recalls and fines.[6]

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